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临床试验/NCT04910412
NCT04910412已完成不适用

Effects of Transcranial Direct Current Stimulation With Gait Training on Lower Limb Performance in Individual With Incomplete Spinal Cord Injury

Mahidol University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年5月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Change from baseline in gait efficacy assessed by walking speed(m/s) at 5 days

研究概览

简要总结

This study aim to investigate the effects of anodal transcranial direct current stimulation combined with gait training for 5 consecutive session on gait performance, balance, sit to stand performance and quality of life in persons with incomplete SCI at post intervention, 1-month follow-up and 2-month follow up

详细描述

The result from the previous studies of Water in 1994 regarding the ambulation status of patients with spinal cord injury (SCI) for a period of 1 year after injury. It was found that 76% of incomplete paraplegia and 46 % of incomplete tetraplegia can recovery their walking ability to become community ambulators. However, the recovery rate gradually decreased and started to hit the plateau level around 9 months post injury or in chronic phase. Therefore, it is a challenge in rehabilitation to restore their functions such as walking which is a primary goal of functional independence.

Activity-based rehabilitation therapy (ABRT) (such as locomotion training) is an intensive intervention that has the potential to promote neurological recovery and enhance walking ability in individual with incomplete SCI. Although, ABRT showed positive results in motor function recovery in incomplete SCI survivors, it may not be able to promote full recovery, especially in chronic patients. Recent studies showed that the combination of training with top-down approach may be an option that could promote motor recovery after SCI.

transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that is currently being used as an add-on treatment in neurorehabilitation. tDCS over the primary motor cortex has been shown to modulate neural activity at both cortical and spinal levels. It also produce an after-effect in modulating neuronal synaptic plasticity and increasing the expression of brain-derived neurotrophic factor (BDNF). Early tDCS studies have shown that increasing stimulation intensity or duration within certain limits enhances tDCS efficacy: while anodal stimulation increases cortical excitability, cathodal stimulation decreases it. The application of tDCS is to place the electrode in a specific montage on the decided target brain area and deliver the low-intensity current pass through that brain area for neural modulation during or after providing a rehabilitation program. Previous studies of the application of tDCS showed that applying of tDCS on primary motor cortex with intensity of 2 milliampere (mA) for 10-20 minutes combined with rehabilitation can enhance lower limb performance such as knee strength, ankle movement, and sit to stand performance in people with stroke as well as walking speed in people with Parkinson's disease. According to result from those previous studies can revealed that the combination of rehabilitation with modulation of corticospinal excitability can enhance lower limb performance in individual with neurological condition. In individuals with incomplete SCI, the excitability of the preserved corticospinal pathways is reduced which can affect the control of their motor skills and motor recovery. Several studies reported positive effect of anodal tDCS combined with training in individuals with incomplete SCI, however most of studies focused on upper limb function. Only few studies on the outcome of lower limb function and walking ability, which are required to return to their daily living and thus increase in quality of life (QOL). Moreover, most of studies in the lower limb were conducted in a small sample size and reported inconclusive results.

Therefore, the purpose of this study is to determine whether the effects of combining anodal tDCS with gait training for 5 consecutive session in people with incomplete SCI can improve lower limb performance consist of gait performance(spatiotemporal), dynamic balance(time up and go test), sit to stand performance (5 times of sit to stand test) and QOL after a prolonged period of follow-up at 1-month and 2-month compare to control group of sham tDCS with gait training.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Spinal Injury Association (ASIA) impairment scale C or D
  • Age between 18-70 years
  • Onset of injury between 1-30 months
  • Ability to walk at least 15 meters with or without walking aid

排除标准

  • Using other orthoses except the ankle-foot orthosis (AFO)
  • Having musculoskeletal pain limiting their walking (pain score > 5/ 10)
  • Modified Ashworth Scale (MAS) greater than 2
  • Having unstable cardiopulmonary disease
  • Having uncontrolled conditions e.g. uncontrolled hypertension, uncontrolled diabetes
  • Having a history of other neurological diseases e.g. stroke
  • Having contra-indication to use tDCS which are
  • The presence of intracranial metal implantation, cochlear implant, or cardiac pacemaker
  • Having an open wound or wound infection on the scalp
  • Having a history of brain surgery
  • Having a history of seizure

结局指标

主要结局

Change from baseline in gait efficacy assessed by walking speed(m/s) at 5 days

时间窗: Baseline and 5 days

10 meter walk test will be used for measuring walking speed in 2 pace which are 1) comfortable pace 2) fastest safe pace by ask the participants to walk along 14-meter walkway and the assessor will record the time at the middle 10 meters and calculate into speed of walking in m/s. Increasing walking speed indicates better walking performance.

Change from baseline in gait efficacy assessed by walking speed (m/s) at 2 months

时间窗: Baseline and 2 months

10 meter walk test will be used for measuring walking speed in 2 pace which are 1) comfortable pace 2) fastest safe pace by ask the participants to walk along 14-meter walkway and the assessor will record the time at the middle 10 meters and calculate into speed of walking in m/s. Increasing walking speed indicates better walking performance.

Change from baseline in gait efficacy assessed by walking speed(m/s) at 1 month

时间窗: Baseline and 1 month

10 meter walk test will be used for measuring walking speed in 2 pace which are 1) comfortable pace 2) fastest safe pace by ask the participants to walk along 14-meter walkway and the assessor will record the time at the middle 10 meters and calculate into speed of walking in m/s. Increasing walking speed indicates better walking performance.

次要结局

  • Change from baseline in gait efficacy assessed by stride parameter (m) at 1 month(Baseline and 1 month)
  • Change from baseline in gait efficacy assessed by stride parameter (m) at 5 days(Baseline and 5 days)
  • Change from baseline in gait efficacy assessed by cadence (step/min) at 1 month(Baseline and 1 month)
  • Change from baseline in balance efficacy assessed by duration of timed up and go test (s) at 2 months(Baseline and 2 months)
  • Change from baseline in balance efficacy assessed by duration of five time sit to stand test(s) at 1 month(Baseline and 1 month)
  • Change from baseline in balance efficacy assessed by duration of five time sit to stand test (s) at 2 months(Baseline and 2 months)
  • Change from baseline in gait efficacy assessed by cadence (step/min) at 5 days(Baseline and 5 days)
  • Change from baseline in balance efficacy assessed by duration of timed up and go test (s) at 1 month(Baseline and 1 month)
  • Change from baseline in balance efficacy assessed by duration of five time sit to stand test (s) at 5 days(Baseline and 5 days)
  • Change from baseline in gait efficacy assessed by stride parameter (m) at 2 months(Baseline and 2 months)
  • Change from baseline in gait efficacy assessed by cadence (step/min) at 2 months(Baseline and 2 months)
  • Change from baseline in balance efficacy assessed by duration of timed up and go test at 5 days(Baseline and 5 days)
  • Change from baseline in quality of life assessed by WHOQOL-Bref Thai version (score 26-130) at 1 month(Baseline and 1 month)
  • Change from baseline in quality of life assessed by WHOQOL-Bref Thai version (score 26-130) at 2 months(Baseline and 2 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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